InspireMD Inc.

Thank you. Ladies and gentlemen, thank you for standing by. Good morning and welcome to SpireMD Third Quarter 2020 Financial Resorts. and corporate update conference call. At this time, all participants are in listen-only mode. If you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Participants of this call are advised that the audio of this conference is being broadcast live over the Internet and is also being recorded for playback purposes. A webcast replay of the call will be available approximately one hour after the call ends through February 9, 2021. I'd now like to turn the call over to Mr. Scott Gordon, president of CoreIR, the company's investor relations firm. Please go ahead.

thank you nick and good morning everyone thank you for joining us for the inspire md third quarter 2020 financial results and corporate update conference call joining us today from inspiremd are marvin slossman chief executive officer inspiring and craig shore chief financial officer during this call management we'll be making forward-looking statements including statements that address inspiremd's expectations will keep the performance or operational results, particularly in light of the COVID-19 pandemic. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For more information about these risks, please refer to Risk Factors described in InspireMD's most recently filed periodic reports on Form 10-K and Form 10-Q, the Form 8-K filed with the SEC today, and AspireMD's press release that accompanies this call, particularly the cautionary statements in it. Content of this call contains quantitative information that is accurate only as of today, November 9th, 2020. Except as required by law, AspireMD explains any obligations publicly updated or revised any information to reflect the events or circumstances that occur after this call. It is now my pleasure to turn the call over to Marvin Foster. Marvin, please. Thank you.

Great. Thank you, Scott, and thank you all for joining the call on the webcast today. While we remain in uncertain times specific to the ongoing COVID-19 pandemic, revenues for the third quarter of 2020 grew both quarter over quarter from 2019 levels and sequentially versus Q2 2020 levels, thus restoring a cautious optimism in our business direction and market recovery. We understand the unpredictable nature of how this pandemic will affect our customers going forward, but feel more prepared to address market needs, having accelerated a higher level of awareness and communication with our channel partners. Investing time over the last two quarters in online training and customer outreach programs have provided us a stronger foundation and transfer of knowledge, which we will continue during this recovery. Through it all, our team remains committed and optimistic, and we are thrilled to have announced the addition of new leadership to drive goal attainment and growth objectives. As for the third quarter, this resurgence of elective procedures in our key markets yielded a 213% increase in total third quarter sales versus the second quarter of 2020, with nearly 50% of those sales occurring in the third month of the quarter. This in no way relaxes our resolve to continue to implement proactive policies and procedures to ensure continued strong performance, including the continued search for more efficient operations and cash management. However, this reinforces our assumption that CAST procedures remain a necessity, notwithstanding the timing delays associated with the COVID-19 outbreak. As for other meaningful milestones, on June 25, 2020, the U.S. FDA granted conditional approval of our Investigational Device Exemption, or IDE, application to initiate a pivotal study of C-Guard EPS. During this quarter, we received the final approval of the IDE application and have begun preparations for the pivotal trial in the United States for C-Guard EPS carotid artery stent. Shortly after the approval, we announced the initiation of our strategic advisory relationship with Dr. Christina Brennan to assist with the planning and execution of the C-Guard Pivotal Study Care Net 3 in the United States. Dr. Brennan brings a wealth of experience to InspireMD and with specific expertise in vascular and stent-related research, in clinical trial development and execution. With more than 20 years of extensive clinical research experience, particularly in the area of carotid artery disease, her leadership will be invaluable now and as we progress on a successful trial effort. I'll return to our clinical development program in a moment, but first I wanted to mention two more recent key hires. First, we welcome Patrick Jamnik as our new Vice President of Business Development and Strategic Initiatives. Patrick will oversee the company's business development activities and play a key role in advancing our short and long-term strategic goals, much of which his focus will be in the U.S. market. As we gain traction and leverage the superior clinical results of our Seaguard EPS stent platform, we will continue to develop new strategic pathways for growth and will look to Patrick's leadership to help get us there. The second hire is our new Senior Vice President of Global Sales and Marketing, Andrea Tomasoli. Andrea's leadership of our global sales and marketing effort is an investment in our customer and commercial focus and provides the essential leadership needed to elevate our growth and acceleration of standard of care of Seaguard EPS. Andrea's experience in leading commercial teams, in particular indirect channel partners globally, adds immediate value to our geographic expansion and higher performance in served markets. And finally, our announcement and appointment of Dr. Gary Rubin to our Board of Directors has reiterated tremendous credibility of our company's direction by the endorsement, active contribution, and financial investment of one of the most renowned and internationally recognized interventional cardiologists in Dr. Rubin. In addition to his formidable achievements in vascular medicine, Dr. Rubin's pioneering work in carotid stenting and embolic protection devices brings a depth of experience and expertise to our business that will be invaluable in our future direction and focus. During his tenure as Chief of Interventional Cardiology at the University of Alabama at Birmingham, and later as Department Chairman and Chief of Services at Lenox Hill Hospital Cardiac and Vascular Programs in New York, he helped bring both programs to international standing in peripheral neurovascular and cardiac interventions. Dr. Rubin's vast experience has enabled him to recognize advanced technical innovations and improve patient outcomes. I could expound on Gary's numerous accomplishments and why we're so thrilled to have him as a part of the board. Ultimately, it's Dr. Rubin's peerless reputation as a clinical scientist, innovator, and interventional cardiologist that lends an important validation to our Micronet technology and the C-Guard stent system. And we believe his presence on the board will also provide meaningful insight, thoughtful direction, and unmatched perspectives in our focus to change the way carotid artery disease is treated and strokes are prevented. He has expressed his confidence in our differentiated Seaguard EPS platform and in our direction that we have undertaken for the business, which is a tremendous vote of confidence, and we're very fortunate to have him join as a director. I would like to turn now to our third quarter results. For the three months ended September 20th, 2020, we generated total revenues of $980,000 as compared to $939,000 for the same period a year ago. and compared to $313,000 during last quarter. This represents a 213% increase sequentially versus last quarter. These results return us to pre-COVID revenue levels, and while we remain cautiously optimistic about the fourth quarter, we're seeing new restrictions instituted to combat the spread of COVID-19, leading to uncertainty to this market impact. Taking a step back as a reminder of the value of our story and foundation of our value proposition, The C-Guard embolic protection system is an advanced platform solution designed to deliver the flexibility of the traditional open-celled stent with what we believe to be the most advanced protection from periprocedural and post-procedural embolic events created by plaque prolapse through the stent strut, which can lead to stroke. C-Guard's unique Micronet technology mitigates the prolapse and associated embolization and continues to demonstrate superior clinical outcomes for patients against alternative carotid stent types, conventional or next generation double layer stents, as well as invasive procedures such as endarterectomy, a major surgical procedure. C-Guard has created a new dimension in protected treatment of carotid artery disease with the potential to truly establish new standard of care for management of carotid artery disease and stroke prevention. That said, our strategic pathway to business growth for C-Guard APS is robust. rooted in broadening market share in endovascular CAS procedures in our served markets, expansion of C-Guard EPS as a first-line stent solution, and focusing ongoing conversions with vascular surgeons to CAS, who perform the vast number of carotid revascularization procedures, more than 80% through carotid endarterectomy. We view carotid artery disease as the next significant vascular condition to advance toward an endovascular standard of care, much of the same way cerebral aneurysms coronary artery disease, thoracic abdominal aortic aneurysms, and peripheral artery disease have. This is why the vascular surgeon and INR, interventional neuroradiology communities, remain a top priority. The most critical step in procedural success is the stent system, which protects the patient just after the procedure, but more importantly, after they leave the hospital. C-Guard EPS continues to demonstrate superiority against all other open-celled, and second-generation covered stent systems and remains the core of our value proposition. We continue to advance our development of a toolset of adjunctive delivery systems and supporting solutions to provide each clinical subspecialty and clinician a range of options to bolster the use of C-Guard EPS as a stent platform, including new next-generation transfemoral and transcarotid delivery platforms. We look to advancing our efforts in these initiatives as we continue to work with our key opinion leaders including vascular surgeons on this strategic direction. And now a word on global expansion. China and Japan represent more than double our current addressable market and as such these markets remain a high priority for the business. We continue discussions with potential distribution partners in both of these regions to expand into these highly valuable Asian markets and look forward to announcing our future progress. In Europe, we are progressing on our application for reimbursement approval in France, which we plan to be a direct sales market once registration is complete. In Brazil, as a reminder, following registration approval last quarter, we've received orders from our distributor partners, completed our training, and have successfully completed our first Seaguard EPS stent procedure. These combined efforts of global expansion, including approval in the U.S. market, remain a priority and a pillar of our commercial focus and growth. With that, I'll turn the call over to Craig to review our second quarter financials. Craig.